FDA Registration
Active
🇺🇸 United States
Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button
Reg #: 3015231789
·
FEI: 3015231789
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Arthrex Manufacturing Inc.
- Registration Number
- 3015231789
- FEI Number
- 3015231789
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 130 Arthrex Drive
- City
- Pendleton
- State
- SC
- ZIP
- 29670
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123341
Owner / Operator
- Firm Name
- ARTHREX, INC.
- Operator Number
- 1220287
- Address
- 1370 CREEKSIDE BLVD., --
- City
- Naples
- State
- FL
- Postal Code
- 34108
- Country
- US
- Correspondent
- Barry Dietz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-03-08 |
Proprietary Names
Arthrex Pec Repair Button, Large Pec Button, Biceps Button and Proximal Biceps Button
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)
Manufacture Medical Device for Another Party (Contract Manufacturer)